Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
phenytoin sodium, Quantity: 30 mg
Viatris Pty Ltd
Capsule, hard
Excipient Ingredients: magnesium stearate; purified talc; Gelatin; carbon black; titanium dioxide; lactose monohydrate; maize starch; sucrose
Oral
200
(S4) Prescription Only Medicine
DILANTIN is indicated for the control of grand mal and psychomotor seizures. DILANTIN will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. Besides its effectiveness in controlling seizures, DILANTIN frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that DILANTIN is valuable in the prevention of seizures occurring during or after neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see Dosage and Administration).
Visual Identification: a white opaque hard gelatin capsule with 'P-D 30' on one end and 'Parke-Davis' on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2017-12-11
DILANTIN ® _phenytoin, phenytoin sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dilantin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Dilantin against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DILANTIN IS USED FOR Dilantin is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Dilantin belongs to a group of medicines called anticonvulsants. These drugs are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Dilantin is also used to help prevent seizures occurring during or after brain surgery. Dilantin may be used alone, or in combination with other medicines, to treat your condition. Your doctor may have prescribed Dilantin for another reason. Ask your doctor if you have any questions about why Dilantin has been prescribed for you. There is no evidence that Dilantin is addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE DILANTIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DILANTIN IF YOU HAVE AN ALLERGY TO: • phenytoin sodium or phenytoin, the active ingredients in Dilantin, or other hydantoin medicines or any of the ingredients listed at the end of this leaflet • methylphenobarbitone or any other barbiturate medicines • other medicines used to treat fits and convulsions. Symptoms of an allergic reaction to Dilantin may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE T Lue koko asiakirja
Version: ujpdilaa10722 Supersedes: ujpdilaa10322 Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION - DILANTIN (PHENYTOIN SODIUM/ PHENYTOIN) 1. NAME OF THE MEDICINE Phenytoin sodium Phenytoin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dilantin ® 30 mg capsules: each 30 mg capsule contains 30 mg phenytoin sodium. Dilantin ® 100 mg capsules: each 100 mg capsule contains 100 mg phenytoin sodium. Dilantin ® Infatabs 50 mg chewable tablets: each 50 mg chewable infatab contains 50 mg phenytoin. Dilantin ® 30 mg/5 mL paediatric oral suspension: each 5 mL of paediatric suspension contains 30 mg phenytoin. Phenytoin is a white, or almost white, odourless or almost odourless, crystalline powder. It is practically insoluble in water and soluble 1 in 70 alcohol. Phenytoin sodium is the sodium salt of phenytoin. It is a white, odourless, slightly hygroscopic crystalline powder. It is soluble in water and alcohol. EXCIPIENTS WITH KNOWN EFFECT: All formulations contain sucrose. The 30 mg capsule new formulation (AUST R 295264) contains lactose monohydrate. The 100 mg capsule (both old and new formulations AUST R 14305 and AUST R 295265) contains lactose monohydrate. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Capsules 30 mg: opaque hard gelatin capsule with white body/white lid, marked ‘PARKE DAVIS’ on one end and ‘P-D 30’ on the other. Capsules 100 mg: opaque hard gelatin capsule with white body/orange lid, marked ‘PARKE DAVIS’ on one end and ‘P-D 100’ on the other. Version: ujpdilaa10722 Supersedes: ujpdilaa10322 Page 2 of 23 Infatabs 50 mg: yellow, triangular, spearmint-flavoured chewable tablets with flat sides, bevelled edge, breaking line on one side and ‘P-D 007’ imprinted on the other. Paediatric suspension: reddish-pink suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dilantin is indicated for the control of generalised tonic-clonic (grand mal) and psychomotor seizures. Dilantin will prevent or effectively decrease the incidence and se Lue koko asiakirja